Cleared Traditional

K151692 - BioArchitects Patient Specific Cranial/Craniofacial Plate

K151692 is an FDA 510(k) clearance for BioArchitects Patient Specific Cranial/..., manufactured by Bioarchitects USA, LLC. The device is a Class 2 Neurology device with product code GXN cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K151692 · Bioarchitects USA, LLC · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
150d
Days
Class 2
Risk

K151692 is an FDA 510(k) clearance for the BioArchitects Patient Specific Cranial/Craniofacial Plate. Classified as Plate, Cranioplasty, Preformed, Non-alterable (product code GXN), Class II - Special Controls.

Submitted by Bioarchitects USA, LLC (New York, US). The FDA issued a Cleared decision on November 20, 2015 after a review of 150 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5330 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K151692

510(k) Number K151692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2015
Decision Date November 20, 2015
Days to Decision 150 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 149d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXN Device Classification - Class 2, Special Controls

Product Code GXN Plate, Cranioplasty, Preformed, Non-alterable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Consultant

Ferguson Medical International Device Consultants, LLC
FRANK FERGUSON

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GXN Plate, Cranioplasty, Preformed, Non-alterable

All 56
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K130447 · Jeil Medical Corporation · Dec 2014
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K133082 · Osteosymbionics, LLC · May 2014
K151692 · BioArchitects Patient Specific Cranial/Craniofacial Plate
Download PDF FDA Summary Bioarchitects USA, LLC